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Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017808

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NDA 017808 describes MIACALCIN, which is a drug marketed by Mylan Ireland Ltd and is included in two NDAs. It is available from three suppliers. Additional details are available on the MIACALCIN profile page.

The generic ingredient in MIACALCIN is calcitonin salmon. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.

Summary for 017808

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 017808

Ingredient-typeCalcitonin

Suppliers and Packaging for NDA: 017808

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIACALCIN calcitonin salmon INJECTABLE;INJECTION 017808 NDA Sebela Pharmaceuticals Inc. 54766-149 54766-149-23 2 mL in 1 VIAL, MULTI-DOSE (54766-149-23)
MIACALCIN calcitonin salmon INJECTABLE;INJECTION 017808 NDA Mylan Institutional LLC 67457-675 67457-675-02 1 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) > 2 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100 IU/ML
Approval Date:Jul 3, 1986TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200 IU/ML
Approval Date:Mar 29, 1991TE:RLD:Yes


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
US Army
Julphar
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US Department of Justice
Harvard Business School
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